Regulatory
The U.S. Food and Drug Administration has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.
Novartis’ Entresto is well on its way to receiving approval as a treatment for heart failure patients following overwhelming support from a U.S. Food and Drug Administration (FDA) advisory committee.
Novartis’ Iptacopan isn’t the only drug to receive Breakthrough Therapy designation this week. Several other experimental treatments were also awarded the designation.
Regeneron Pharmaceuticals reported that it is pausing enrollment in two of its clinical trials for odronextamab for lymphoma. The U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trials.
All eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
As the year wraps up, there are still some PDUFA dates on the agency’s calendar. Read on for this week’s.
If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.
Sanofi announced yesterday that they will resume dosing in U.S. clinical trials. They noted that on October 30, they had “voluntarily paused dosing in all ongoing fitusiran clinical studies … to assess reports of non-fatal thrombotic events in patients participating in the Phase III program.”
The U.S. Food and Drug Administration (FDA), a day after a positive advisory committee recommendation, granted an Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine. Dosing is expected to begin in days.
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